NRP
5 FDA 510(k) clearances · Product code
125 daysmedian time to decision
212 days90th percentile
5clearances measured
FDA profile
- Official device name
- Sirolimus Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3840
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- FDA definition
- Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.
- Adverse events (MAUDE)
- 2006: 3 · 2010: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR (K083487) | Siemens Healthcare Diagnostics | 2009-03-30 |
| DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 (K081857) | Siemens Healthcare Diagnostics, Inc. | 2008-10-30 |
| ARCHITECT SIROLIMUS ASSAY (K070822) | Fujirebio Diagnostics,Inc. | 2007-09-28 |
| ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY (K042411) | Axis-Shield , Ltd. | 2005-04-07 |
| CEDIA SIROLIMUS ASSAY (DEN040008) | Microgenics Corp. | 2004-07-28 |
Track NRP automatically
Every clearance here is in the API, with alerts when new ones post.